Candel Therapeutics to Present Phase 3 Results of CAN-2409 in Localized Prostate Cancer at ASTRO 2025

Rhea-AI Summary

Candel Therapeutics (NASDAQ:CADL) announced the acceptance of their abstract for oral presentation at the 2025 ASTRO Annual Meeting in San Francisco. The presentation will showcase results from their Phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer.

Dr. Glen Gejerman from Hackensack University Medical Center will present the findings of the randomized, placebo-controlled study evaluating CAN-2409+Prodrug in combination with standard EBRT for newly diagnosed localized prostate cancer. The presentation is scheduled for September 28, 2025, at 2:30 PM PT. The abstract has also been selected for ASTRO's Science Highlights - Genitourinary Cancer session.

NEEDHAM, Mass., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that an abstract was accepted for an oral presentation at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting, taking place from September 27 to October 1, 2025, in San Francisco, CA. The oral presentation will feature data from the Company’s phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer.

Details are as follows:

CAN-2409 – Localized Prostate Cancer

• Abstract Title: Phase 3, Randomized, Placebo Controlled Clinical Trial of CAN-2409+Prodrug in Combination with Standard of Care External Beam Radiation (EBRT) for Newly Diagnosed Localized Prostate Cancer
  
• Presenter: Glen Gejerman, MD, MBA, Hackensack University Medical Center, Hackensack, NJ
  
• Session Title: SS 03 - GU 1: Advances in Localized Prostate Cancer
  
• Session Date/Time: Sunday, September 28, 2025; 2:30 PM - 2:40 PM PT
  
• Location: Room 24, Moscone Center, San Francisco, CA
  
  

The abstract has also been selected for inclusion in ASTRO’s Science Highlights - Genitourinary Cancer session on Sunday, September 28 at 8:00 a.m. PT in Room 24, which will provide a high-level overview of top-rated research in the field.

About Candel Therapeutics

Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf, multimodal viral immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical-stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform.

The Company recently completed a pivotal, placebo-controlled, phase 3 clinical trial of CAN-2409 in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the U.S. Food and Drug Administration (FDA), which achieved the primary endpoint supported by secondary endpoints. The Company also reported successful phase 2a clinical trials of CAN-2409 in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC). The FDA also granted Regenerative Medicine Advanced Therapy Designation to CAN-2409 for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease. The FDA had previously granted Fast Track Designation to CAN-2409 in NSCLC and prostate cancer, and Fast Track Designation and Orphan Drug Designation to CAN-2409 in PDAC.

CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma. Initial results were published in Nature and CAN-3110 received Fast Track Designation and Orphan Drug Designation from the FDA. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors.

For more information about Candel, visit: www.candeltx.com.

Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat solid tumors; and expectations regarding the potential benefits conferred by regulatory designations. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

Investor Contact
Theodore Jenkins
Vice President, Investor Relations and Business Development
Candel Therapeutics, Inc.
tjenkins@candeltx.com

Media Contact
Ben Shannon
Vice President
ICR Healthcare
CandelPR@icrhealthcare.com

FAQ

When will Candel Therapeutics (CADL) present their Phase 3 prostate cancer trial results at ASTRO 2025?

Candel Therapeutics will present on Sunday, September 28, 2025, at 2:30 PM PT at the Moscone Center in San Francisco.

What is the Phase 3 trial of Candel Therapeutics' CAN-2409 studying?

The trial is studying CAN-2409+Prodrug in combination with standard external beam radiation (EBRT) for newly diagnosed intermediate-to-high-risk localized prostate cancer.

Who will present Candel Therapeutics' Phase 3 prostate cancer data at ASTRO 2025?

Dr. Glen Gejerman from Hackensack University Medical Center will present the Phase 3 trial results.

Where can investors view Candel Therapeutics' ASTRO 2025 presentation?

The presentation will take place in Room 24 at the Moscone Center, San Francisco. The abstract will also be featured in ASTRO's Science Highlights session at 8:00 AM PT.